Mycobacterium Avium ComplexPhase 4NCT00598962
Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
A Phase 4 study testing Azithromycin and Rifabutin/rifampin in people with Mycobacterium Avium Complex, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
Trial summary
To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium Complex
- What is being tested?
- Azithromycin and Rifabutin/rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1994to 18 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
- Age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
- Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
- Available for long term followup
Who cannot join
- History of macrolide or rifamycins allergy
- Laboratory evidence of mycobacterial resistance to azithromycin
- Children less than 18 years of age
- If a menstruating female, not pregnant and on adequate birth control
- HIV+ or at risk
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
About this study
Official title: Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)
Read the detailed description
Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
- Conditions
- Mycobacterium Avium Complex
- Being tested
- Azithromycin, Rifabutin/rifampin
- Keywords
- MAC
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Rifabutin/rifampinDrug
Also called mycobutin/
| Study group | Role | What they receive |
|---|---|---|
| azithromycin and rifabutin/rifampin | Experimental | Azithromycin and rifabutin/rifampin administered three times weekly. Receives: Drug: Azithromycin; Drug: Rifabutin/rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
neg cultures X3 ( sputum conversion)
Measured: 6 months
Secondary outcomes (1)
Microbiological cultures
neg culture 1 yr on treatment
Measured: 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startDec 1994
- Primary completionNov 2006
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium ComplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
- Investigators
- Richard J Wallace Jr., M.D., Principal investigator, The University of Texas Health Science Center at Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598962
- Sponsor's protocol ID
- 426
- Status last verified
- May 2017
- First submitted
- 11 Jan 2008
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
- ClinicalTrials.gov ID
- NCT00598962
- Acronym / sponsor ID
- 426
- Conditions
- Mycobacterium Avium Complex
- Keywords
- MAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 1994 (actual)
- Primary completion
- Nov 2006 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)
Detailed description
Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azithromycin and rifabutin/rifampin | Experimental | Drug: Azithromycin, Drug: Rifabutin/rifampinAzithromycin and rifabutin/rifampin administered three times weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
- Age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
- Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
- Available for long term followup
Key exclusion criteria (5 listed)
- History of macrolide or rifamycins allergy
- Laboratory evidence of mycobacterial resistance to azithromycin
- Children less than 18 years of age
- If a menstruating female, not pregnant and on adequate birth control
- HIV+ or at risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: ZithromaxDosage dependent on clinical factors such as age, weight and patient-specific health status | Drug | azithromycin and rifabutin/rifampin |
| Rifabutin/rifampinAlso: mycobutin/ | Drug | azithromycin and rifabutin/rifampin |
Primary outcome
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Time frame: 6 months
neg cultures X3 ( sputum conversion)
1 secondary outcome
Microbiological cultures
Time frame: 1yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Wallace Jr., M.D. principal investigator
The University of Texas Health Science Center at Tyler
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Rifabutin/rifampin in people with Mycobacterium Avium Complex, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.